Two years into the pandemic, wealth, poverty and race still dramatically affect the toll the coronavirus takes on people, with Latinos and Black communities in L.A. County continuing to be significantly harder hit than wealthier white ones.
Data analyzed by Los Angeles County public health officials showed disturbing inequities in the disproportionate toll COVID-19 was causing for Black and Latino residents, as well as people living in poorer neighborhoods.
The findings underscore how much poorer and largely Black and Latino neighborhoods of L.A. County could suffer should the improvement in pandemic trends suddenly reverse as mask mandates ease, or the need for quick action comes if a new variant emerges.
These data on hospitalizations and deaths are alarming, L.A. County Public Health Director Barbara Ferrer said at a Board of Supervisors meeting on Tuesday. We have to ensure that our post-surge actions do not widen the gaps by failing to provide additional resources and protections to those at highest risk for COVID-19 hospitalization and death.
Between Jan. 29 and Feb. 11, for every 100,000 unvaccinated residents in each racial or ethnic group, 74 Latino and 60 Black residents were hospitalized for COVID-19, while 43 white and 30 Asian American residents were.
In other words, unvaccinated Latino and Black residents are at least twice as likely as unvaccinated Asian American Angelenos to be hospitalized for COVID-19.
Those racial and ethnic disparities persisted even among vaccinated people who received their booster shots. For every 100,000 vaccinated and boosted residents, 13 Latino and 11 Black people were hospitalized, while five white and three Asian American residents were.
These differences partially reflect higher rates of underlying health conditions among Black and brown residents due to inadequate access to health-affirming resources. And theyre also likely to reflect differences in exposure to COVID based on where individuals live and work, Ferrer said. Regardless of vaccination status, living in an area with high poverty was associated with a substantially higher risk for hospitalization.
Many Black and Latino residents, as well as low-income residents, in L.A. County live in areas with less access to resources such as hospitals and pharmacies.
Its really clear that where you live and where you work has an impact on your health status. Its no different for COVID than it is for a host of other illnesses, Ferrer said at a briefing last week. Certainly where you live has a tremendous impact on whats available to help you be as healthy as possible.
Many Latino and Black residents live in areas where government officials for generations have neglected residents public health, in part due to a legacy of racism and discrimination. Neighborhoods such as South L.A., southeast L.A. County and the Eastside are blanketed by a web of freeways spewing toxic pollution, increasing the risk of asthma and other chronic conditions that place those residents at greater risk of COVID-19 complications.
Residents who live in crowded housing, where its easier for a highly infectious, airborne virus to spread, are also more vulnerable to COVID-19. In addition, many lower-income, as well as Black and Latino residents, need to physically leave home to work in a frontline job, where the risk of being exposed to the coronavirus is higher.
People living in wealthier areas, by contrast, have had a number of advantages during the pandemic: better access to hospitals, a higher chance of living in uncrowded homes and cleaner air thanks to a lack of nearby freeways (Beverly Hills and South Pasadena memorably fought off construction of freeways through their cities).
Those systemic, structural issues of living in a place close to freeways can quickly result in worse COVID-19 outcomes. For instance, air pollution can worsen asthma symptoms. Black, Latino and Native American residents nationwide are more likely to suffer from asthma, according to the Asthma and Allergy Foundation of America. And people suffering from asthma are at higher risk of having severe illness or death from COVID-19, Ferrer said.
Troubling disparities have also been seen in COVID-19 deaths. Between Jan. 23 and Feb. 5, for every 100,000 unvaccinated residents in each racial and ethnic group, 47 Latino residents died, compared with 32 white, 22 Black and 16 Asian American residents.
Among those who are vaccinated and boosted, for every 100,000 people, three Latino and two Black residents died, compared to one each among white and Asian American residents.
There also were stunning COVID-19 disparities based on socioeconomic status and where people lived. From Jan. 29 to Feb. 4, for every 100,000 unvaccinated residents divided into groups by their areas poverty status, eight people living in the countys wealthiest areas died, compared to 76 in the countys poorest areas.
And even among vaccinated and boosted residents, the disparities remained: For every 100,000 residents, one died in the wealthiest areas, while three died in the poorest areas.
Its clear that living in areas of high poverty is putting people at risk for higher COVID-19related severe illness and death, Ferrer said. Despite the strong protection that vaccines afford, getting vaccinated alone was not an equalizer for people living in areas of high poverty. Where people live and work clearly has a tremendous impact on their risk of exposure, and the availability of health-affirming resources.
The differing effects of COVID-19 on Black and brown communities, as well as low-income areas, probably helps explain the dynamics on the L.A. County Board of Supervisors, which has been divided over how quickly to lift the indoor mask mandate in the nations most populous county.
Of the five supervisors, Hilda Solis and Holly Mitchell the sole Latina and Black representatives, respectively have in recent weeks backed efforts to keep the countys mask mandate in place for a few weeks longer, and have routinely voiced concerns about the disproportionate impact the pandemic has had on their constituents. Solis and Mitchell were elected from districts that have the highest poverty rates and lowest median household income, according to an analysis published by the L.A. County Economic Development Corp. in 2017.
A third supervisor who has backed a slower lifting of mask mandates, Sheila Kuehl, was elected from a district that has a poverty rate and median household income between the wealthiest and poorest districts.
By contrast, Supervisors Kathryn Barger and Janice Hahn were elected from districts with the lowest poverty rates and highest median household income. Both have been vocal about easing mask mandates to be as lenient as the state allows. They say they get many complaints from residents wanting mask mandates to be lifted faster.
'Pancorona virus vaccine will combat all corona virus variants: Dr Drew Weissman
Hyderabad, Feb 24 (UNI) BioAsia 2022 Genome Valley Excellence Award recipient, Dr. Weissman on Thursday said we are making a ' pancorona virus' vaccine which will protect against all coronavirus variants.The 19th edition of BioAsia, on its inaugural day held in virtual mode Thursday , held a special fireside chat, which witnessed a revolutionary revelation on the future of the coronavirus vaccination by Dr. Drew Weissman.In a conversation with Apollo Hospitals Managing Director Dr. Sangita Reddy, Dr Wissman elaborate extensively on the pancorona viruses, the state of costs in healthcare, and the future of mRNA in therapeutics.There have been three coronavirus epidemics in last years and there are going to be more. So, we want to create a vaccine that will stop any coronavirus from infecting humans. We are developing a few and they look promising, he said.The future of mRNA technology is noted to be tremendously promising, with an array of uses. It can also be used in therapeutics, he said.Dr. Weissman and his lab envision developing mRNA therapy for neurologic events, strokes, embolic events, as a way for reducing inflammation. My biggest hope is its use in gene therapy. Someday, it might be possible to treat genetic diseases like Cystic fibrosis, he told.Dr. Weissman also indicated an optimistic outlook for India in terms of collaborations to build mRNA production sites. In his closing remarks, he voiced strongly against the misinformation on vaccines.He said On a societal and systematic level, equality of therapeutics is important. Cost being the main problem, government and privately funded research can magnanimously help in bringing down costs and make it accessible across the world.A globally renowned researcher in mRNA technology for the rapid development of effective COVID-19 vaccines, Dr. Weissman, in collaboration with Dr. Katalin Karik, discovered the ability of modified nucleosides in RNA to suppress activation of the innate immune sensors and increase the translation of the nucleoside-modified mRNA. This outstanding discovery was used in the first two approved COVID-19 vaccines by Pfizer and Moderna.The striking result of the modified RNA vaccines was the incredibly high efficacy.Within 12- days of the second dose, the infections in the vaccinated people were extinct, with nearly 95 percent efficacy, he said. When you inject mRNA, it kills the tissue due to severe inflammation. But we developed a new type of RNA that is not inflammatory this RNA used in vaccines is incredibly effective and safe, the researchers said.Over a billion people have received the RNA vaccines so far and there have been almost no adverse events, he said during BioAsia 2022.RNA is a complex molecule that is simple to make, making it an ideal, cost-effective technology to introduce to other vaccine development.Dr. Weissman continues to develop other vaccines to induce potent antibody and T-cell responses with mRNA-based vaccines.Speaking on the development of future vaccines, he said, We are working on many different vaccines for a variety of pathogens including HIV, HCV, HSV, Malaria, Influenza, and pancorona viruses. We are also working on vaccines for food allergies, cancer vaccines, autoimmune diseases, therapeutics and In vivo gene therapy.Dr. Weissman observed that Coronavirus like any other RNA viruses is prone to a lot of mutations. The variants are going to keep coming as long as there's widespread infection. We have only vaccinated 15 percent of Africa and we've immunized low levels of many countries in the world. Until the world is fully vaccinated, the virus will continue to mutate, he stated.There are 2 options here, observes Dr. Weissman, you can keep making new vaccines every time there is a new variant. But it is important to note the low life span of these variants to keep up with this cycle, he added.UNI KNR SY 1531
One shot, two shot; red shot, blue shot. The vaccines might not have been successful in slowing the spread of SARS-CoV-2 one iota, but they were successful in earning profits for the manufacturers. Logically, they would like to repeat this pleasurable experience with other viruses safety, past failures, and common sense be damned.
If you like the success of the mRNA vaccines against SARS-CoV-2 in stopping the virus, you will love the slate of new mRNA vaccines coming to a neighborhood near you, according to Modernas CEO. Once upon a time, we could rely on our government and even the pharmaceutical companies to abort efforts to pursue failed vaccines when they proved to be dangerous during clinical trials, such as with the attempted dengue fever and RSV vaccines. Now that they plan to develop more vaccines by 2023, do you really have the confidence that they will still act upon dangerous safety signals?
During a World Economic Forum panel discussion last week titled, COVID-19: Whats Next? Moderna CEO Stphane Bancel revealed (at 7:20) the next step of the vaccine wars:
When moderator Francine Lacqua asked Bancel how close the company is to achieving this goal, here was his response:
So the RSV program is now in Phase 3, the flu program is in Phase 2 and soon in Phase 3, I hope as soon as second quarter of this year. So the best-case scenario would be the fall of 2023, as a best-case scenario, I dont think it would be in every country, but we believe its possible to operate in some countries next year.
Judging by the past two years, this means that no number of negative safety signals will stop this shot. After all, they want to make sure there are no compliance issues.
The public needs to be aware of the fact that there is no effective vaccine against respiratory viruses. We now see that the COVID vaccines never stopped transmission and likely turned negative after a few months, which is why they pushed the boosters and Fauci is now floating a second booster. Flu shots as well are spotty at best. One could not possibly conjure up a worse collection of illnesses for which to pursue vaccines. Respiratory virus vaccines have always failed in the past, and now we know why. Both the RSV and dengue fever vaccines have failed because they created antibody-dependent disease enhancement (ADE), where they made the vaccinated sicker from the pathogen.
Childrens Hospital of Philadelphia (CHOP) has a page on its website about ADE and its history with the failed RSV and dengue fever vaccines. ADE occurs when the antibodies generated during an immune response recognize and bind to a pathogen, but they are unable to prevent infection, writes CHOP. Instead, these antibodies act as a Trojan horse, allowing the pathogen to get into cells and exacerbate the immune response.
Sound familiar? What recent vaccine do we know failed to stop transmission and in fact, in later months, caused the vaccinated to get infected at higher rates? Oh, thats right, a coronavirus vaccine.
CHOP explains that this is exactly what happened with the failed RSV vaccine in 1967:
In clinical trials, children who were given the vaccine were more likely to develop or die from pneumonia after infection with RSV. As a result of this finding, the vaccine trials stopped, and the vaccine was never submitted for approval or released to the public.
Indeed, the RSV vaccine was an utter disaster, resulting in the hospitalization of 80% of the infants and toddlers in the clinical trial. There has not been a successful RSV vaccine since then.
This was back when we actually nixed dangerous vaccines. Do you have any confidence that the company would respond in kind and be transparent about it today were the trials to pick up inchoate signs of injuries, ADE, or leaky vaccine hypothesis?
More recently, in 2016, hundreds of thousands of children in the Philippines were injected with a vaccine that made some of them very sick. Fourteen children reportedly died. The concern at the time was that those without prior infection wound up getting more seriously ill from the pathogen after having had the vaccine, which is why the shot is only available today for those who, ironically, already had the disease.
In other words, ADE is a real concern with respiratory virus vaccines, especially one of them mentioned by Bancel. Lets not forget that on page 52 of the FDA's "Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum," it states that there appears to be no concern of ADE in the short run (during the original strain), but "risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials and in observational studies that could be conducted following authorization and/or licensure."
Well, why is this not revisited a year later, now that everyone agrees there is waning immunity?! We see record infections across the board, a higher rate of infection among the vaccinated, waning immunity, and a need for endless boosters, and we know they never ruled out ADE, by their own admission. Yet now they want to tether this vaccine to yet another respiratory virus that already had a proven manifestation of ADE in a failed vaccine candidate!
The other candidate for the mRNA deluxe triple combo is an annual influenza vaccine. But we already know that the flu vaccine is clearly non-sterilizing, and furthermore, there is already evidence of instances of negative efficacy. A Canadian study published in Euro Surveillance just days before the start of the coronavirus pandemic found a -346% vaccine efficacy rate of the flu shot for those ages 35-54 during the 2018-19 late-season influenza A(H3N2) epidemic. H3N2 is the predominant flu circulating this season. Clade 3C.3a VE showed a pronounced negative dip among 3554-year-olds in whom the odds of medically attended illness were>4-fold increased for vaccinated vs unvaccinated participants (p<0.005), concluded the authors.
Shouldnt we have an independent audit of consumer advocates studying these vaccines before we allow the government and the people who stand to make billions of dollars foist them upon us with liability protection?
Fauci himself was also a speaker at this forum with Bancel. Lets not forget that at the beginning of the pandemic, he warned that part of the safety concern of a rushed vaccine is that it might make the pathogen worse. Theres another element to safety, and that is: If you vaccinate someone and they make an antibody response, and then they get exposed and infected, does the response that you induced actually enhance the infection and make it worse? warned Fauci in an interview with Facebook CEO Mark Zuckerberg in March 2020. In cautioning why you cant just produce a vaccine out of thin air, Fauci explained, The only way youll know that [if the vaccine makes the pathogen worse] is if you do an extended study, not in a normal volunteer who has no risk of infection, but in people who are out there in a risk situation. This would not be the first time, if it happened, that a vaccine that looked good in initial safety actually made people worse.
Which example did he give? The very virus for which Moderna is now working on an mRNA vaccine. There was a history of the respiratory syncytial virus vaccine in children which, paradoxically, made the children worse, continued Fauci. One of the HIV vaccines that we tested several years ago actually made individuals more likely to get infected. So, you cant just go out there and give it unless you feel that, in the field, when someone is getting infected and exposed, being vaccinated doesnt make them worse.
During the forum with Fauci, the Moderna CEO said he is collaborating with Dr. Faucis team on this proposed triple combo vaccine. He also said (at 44:01) that he would be working on targeting 20 other pathogens, including Nipah and Zika. All of these vaccines for respiratory viruses run the risk of causing some form of ADE and original antigenic sin, especially if the new modus operandi is to release them to the public before conducting studies that rule out these pernicious unintended consequences of imperfect vaccines.
By Kristen Hwang, CalMatters
Deondray Moore sat in a plastic folding chair, rolled up his sleeve and got his first COVID-19 shot in the parking lot of Center of Hope Community Church in Oakland a week ago. He was the last in his family to get vaccinated after putting it off for more than a year, and only acquiesced because he wants to be in the delivery room when his son is born this summer.
My mom has been trying to get me vaccinated forever, since the (vaccines) came out, Moore said. My partner got it quick, and her kids got it as fast as they could. She wasnt playing around. She was like Dont miss out on the baby.
The 35-year-old Oakland native, an African American, knows multiple people who have contracted COVID-19 and died. Moore wears a mask and doesnt go out much. But hes suspicious of the vaccine and the way it was developed. I just dont trust the government, he said.
African Americans, who have alitany of historical reasonsto mistrust public health officials and doctors, have the lowest vaccination rate in the state, at 55%.
COVID-19 has become deadlier for Black Californians since the widespread availability of vaccinations, and vaccine hesitancy could be among the reasons why. Other races, which have higher vaccination rates, have seen death rates rise, but not as dramatically.
A CalMatters analysis shows since last summer, the rate of Black Californians dying from COVID-19 has increased tenfold from one death per 100,000 people last July to 10.4 deaths this week. That surpasses Latinos and all races exceptPacific Islanders, who are dying at the rate of 14.7 per 100,000, according tostate data.
And while statewide deaths from COVID have declined in the past week, they have continued to rise for African Americans.
So far, 5,544 Black people have died from the virus in California.
Dr. Kim Rhoads, an associate professor of epidemiology at University of California, San Francisco, said she isnt surprised by the growing death rate among African Americans. Disparities arent new. They arent new to COVID, said Rhoads, who helped organize the community clinic where Moore got his shot.
For some Black residents, the disparity grew worse after vaccines became widely available last summer, according to astudyfrom UC Santa Cruz and UC San Francisco researchers.
Middle-aged Blacks make up a growing, disproportionate share of the Californians who died, while the proportion shrank for Latinos and others: In March 2021, Black people aged 40-64, who make up roughly 5% of all middle-aged Californians, accounted for 6% of COVID-19 deaths in that age group. But a few months later, their numbers skyrocketed, accounting for 21% by last July, according to the study.
In contrast, middle-aged Latinos accounted for 66% of all COVID-19 deaths at the beginning of March 2021, but then last July shrank to 30%, mirroring their proportion of all middle-aged Californians.
Lead researcher Alicia Riley said preliminary data through November shows continuing disparities.
So why did the vaccines apparently help Latinos but not Black Californians? Its possible that those who are most at risk of dying from the disease arent getting vaccinated. Younger African Americans also may not have been included in early vaccination campaigns or may have felt they werent at risk of severe illness or death.
Whats puzzling to me is that they have a really different story in terms of whos dying, said Riley, a UCSC assistant professor of global and community health. Are the people who were at risk of dying in the Latino community actually being reached with vaccination, whereas somehow thats not happening for Black Californians as effectively?
Experts say myriad other factors could also be driving the trend, including poverty, lack of insurance, distrust of the health care system and higher rates of health complications like diabetes or heart disease.
The increased share of deaths for Black Californians is a powerful sign of who was left behind when everyone else was kind of moving on out of the pandemic, Riley said.
The study did not find significant differences for other age groups, although state data suggests Black children fare worse than other races, too.
Black children in California are the second most likely to die from the virus among Californians younger than 18, with 1.2 deaths per 100,000 Black children. Pacific Islanders are twice as likely to die from COVID as Black children, while all other races have less than one COVID-19 death per 100,000 children.
The drivers for African American deaths are likely deeper than vaccination disparities.
Rhoads, who studies death disparities in Black cancer patients, said pre-existing health complications also arent entirely to blame. Structural factors like poor quality health care also likely contribute to higher death rates, she said. For instance, medical devices like the pulse oximeter, which is used to determine whether a patient needs supplemental oxygen,dont work well on dark skin.
If we just say comorbidities, then were blaming the victim number one and were washing our hands of any responsibility, Rhoads said.
Substantial gains have been made among Latinos, according to Rileys study. After bearing the brunt in the early stages, Latinos death rate dropped from nearly 25 deaths per 100,000 people in January 2021 to 1 death per 100,000 in July. Over the last month, theCalifornia Department of Public Health estimates7.2 Latinos died of COVID per 100,000 people, lower than the statewide rate of 8 per 100,000.
Around June 2021 the percentage of fully vaccinated Latinos outstripped Blacks and Native Americans, leaving Blacks in last place. Only 57% of Latinos are fully vaccinated, but somehard hit agricultural areas like Imperial Countywere quick to accept the vaccine and it has made a difference.
Eduardo Garcia, senior policy manager for the Latino Community Foundation, said high death rates among Latinos early in the pandemic galvanized local groups and clinics to dole out vaccines and combat misinformation.
Over 34,000 California Latinos have died since the beginning of the pandemic, Garcia said. It touched people close to home. I think that also created an impulse for people to get information from reliable sources and get the vaccine.
Rhoads said refocusing COVID-19 vaccination messaging on preventing deaths rather than infections is important for equity, particularly since getting her community to trust the vaccine has been harder.
Its about a historical relationship between Black people and public health and health care, Rhoads said. Instead of saying lack of trust, Im saying theres no relationship there, so there should be no expectation of trust.
That trust was further shaken last spring when the Food and Drug Administration warned of rare but severe side effects associated with the Johnson and Johnson vaccine. Rhoads said the number of people seeking vaccinations at her clinic dropped precipitously.
To help bridge the gap, Rhoads founded Umoja Health, a collective of community and faith-based organizations in the Bay Area, to make COVID-19 testing and vaccination easy and accessible for African Americans. They bring pop-up clinic supplies to churches, schools and neighborhoods where they know vaccination rates are low. It takes patience and continued effort, Rhoads said.
At Castlemont High School in Oakland, where the clinic frequently sets up shop, it was several weeks before many Black students trusted them enough to get the vaccine.
The Latino students came immediately, she said. But as weve been there over time, were starting to see more and more of the African American students come through, and then we started to see people bringing their parents.
Gov. Gavin Newsoms recent announcement that California would be moving into anew phase of the pandemicworries advocates and community health organizers like Rhoads.
The newstate action planacknowledges continuing disparities when it comes to COVID-19 deaths and highlights money in Newsoms budget that includes $819 million to expand Medi-Cal to undocumented individuals next year, $1.7 billion to invest in a more diverse health care workforce over five years and$65 millionto fund the creation of an office of community partnerships and strategic communication.
But the plan offers little in terms of immediate action to fix disparities, and includes no specific programs to help Black communities.
The state health department on Thursday announced new $27 million contracts would be awarded to more than 100 community-based health organizations to shore up vaccination efforts in underserved communities, including African American ones.
However, community advocates worry that rhetoric used by Newsom like turning the page on the pandemic will ultimately prevent groups that have never caught up from moving forward.
We still have growing death rates and case rates. How can we move forward in the pandemic when were still suffering? said Karla Thomas, policy director for theUCLA Native Hawaiian and Pacific Islander COVID-19 Data Policy Lab.
Throughout the pandemic, Pacific Islanders have beenhit the hardest by COVID-19. Their mortality rate is nearly twice that of the statewide rate and nearly six times higher than the lowest rate of 2.5 deaths per 100,000 people among those who identify as multi-racial.
While data suggests that Pacific Islanders are nearly 100% vaccinated, Thomas said there is reason to believe that the states numbers are inaccurate. At times that number has creeped above 100%. From a personal experience, Thomas said she is one of only two people in her 50-person Samoan church in San Bernardino that she knows is vaccinated. Its not uncommon for there to be more than two funerals a month in her community.
Im really concerned that were not taking an equitable approach to mitigate the pandemic among (Native Hawaiian and Pacific Islander) communities and other communities of color, Thomas said. She criticized the lifting of the states mask mandate on Feb. 15 and the governors endemic plan.
Rhoads echoed Thomas sentiments.
The pandemic is not over. Its not for people who arent vaccinated, who dont have regular health care, she said.
Last week Rhoads and more than 35 organizations sent a letter to the state health department in part criticizing the states inconsistent and confusing messaging on masking. The health departments initial criteria for lifting the indoor mask mandate included vaccination and infection rates that were unmet when the mandate expired.
Rhoads said instances like this erode public trust in government and scientific organizations, particularly among groups that placed little faith in the institutions to begin with.
In response, the department agreed to schedule a meeting between Rhoads and State Public Health Officer Dr. Tomas Aragon.
In a separate response to CalMatters, the state health department said vaccine equity was the north star of its efforts to reach marginalized communities, and that it would continue to partner with community organizations, ethnic media, translators and faith-based groups.
This work is ongoing, and closing the equity gap across all California communities remains a priority to the states vaccination efforts, the department said in a statement.
In Oakland at the Umoja clinic last week, George Dowell, a 40-year-old African American, said he was getting his second vaccination dose because he didnt want to be left behind as more and more businesses require proof of vaccination for entry.
Dowell is among the age group experiencing higher death rates in Rileys study. He spent the past year watching vaccinated friends and family carefully for side effects before deciding to get the shot himself.
Social media and misinformation played a role in Dowells hesitation. I was listening to certain people, social media, instead of listening to myself and doing whats right, Dowell said.
Three weeks ago, he decided it was time. He found the Umoja clinic while driving around the neighborhood and got his first Pfizer shot. Dowell wanted to show his school-aged nieces and nephews that there was nothing to be afraid of as they became eligible for the vaccine.
Dowells 27-year-old son is also unvaccinated, and Dowell said he promised he would call to let him know how he feels after this second shot.
To evaluate the immunogenicity of the Sanofi-GSK vaccine as a booster, human immune sera samples were tested by Monogram Biosciences [San Francisco, CA] using an FDA-approved standardized pseudovirus neutralization test (pVNT) against the D614G prototype virus.
About VAT08 and VAT02The Phase 3 trial, VAT08 is evaluating a 10g antigen formulation of the SARS-CoV-2 adjuvanted recombinant protein-based vaccinefor efficacy, immunogenicity and safety compared to a placebo. Stage one of the trial is assessing the efficacy of a vaccine formulation containing the spike protein against the original D614 (parent) virus in more than 10,000 participants >18 years of age, randomized to receive two doses of 10g vaccine or placebo at day 1 and day 22 across sites in the US, Asia, Africa and Latin America. Enrolment recently completed for a second stage in the trial, evaluating a second bivalent formulation, including the spike protein of the B.1.351 (Beta) variant. The Phase 3 trial follows positive initial results from a Phase 2 clinical trial (VAT00002). In that trial, the COVID-19 vaccine candidate was administered to 722 adults to assess the safety, reactogenicity and immunogenicity of 2 doses and to identify an optimal dosing for use as a booster. Results showed strong rates of neutralizing antibody response with 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old), across all doses.
Full study results for both VAT08 and VAT02 will be published later this year.
These efforts are supported by federal funds from the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract # W15QKN-16-9-1002 and by the National Institute of Allergy and Infectious Diseases (NIAID). The NIAID provides grant funding to the HIV Vaccine Trials Network (HVTN) Leadership and Operations Center (UM1 AI 68614HVTN), the Statistics and Data Management Center (UM1 AI 68635), the HVTN Laboratory Center (UM1 AI 68618), the HIV Prevention Trials Network Leadership and Operations Center (UM1 AI 68619), the AIDS Clinical Trials Group Leadership and Operations Center (UM1 AI 68636), and the Infectious Diseases Clinical Research Consortium (UM1 AI 148684, UM1 AI 148450, UM1 AI 148372 , UM1 AI 148574).
About the Sanofi and GSK partnership In the collaboration between the two companies, Sanofi provides its recombinant antigen and GSK contributes its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza.
About GSKGSK is a science-led global healthcare company. For further information please visit www.gsk.com/about-us.
About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Cautionary statement regarding forward-looking statementsGSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020, GSKs 2021 Q4 Results and any impacts of the COVID-19 pandemic.
The vaccine deployment in December 2020 signaled a turning point in the COVID-19 pandemic. By the end of May 2021, 40% of the U.S. population was fully vaccinated. But as vaccination rates lagged over the summer, new surges of COVID-19 came, including Delta in the summer of 2021, and now the Omicron variant, which comprises the majority of cases in the U.S.
Researchers around the world have reported that Omicron is more transmissible than Delta, making breakthrough and repeat infections more likely. Early research suggests this strain may cause less severe illness than Delta and the original virus, however, health officials have warned an Omicron-driven surge could still increase hospitalization and death rates, especially in areas with less vaccinated populations.
The United States as of Feb. 25 reached 946,481 COVID-19-related deaths and 78.8 million COVID-19 cases, according to Johns Hopkins University. Currently, 64.8% of the population is fully vaccinated, and 43.5% have received booster doses.
Stacker compiled a list of the counties with highest COVID-19 vaccination rates in California using data from the U.S. Department of Health & Human Services and Covid Act Now. Counties are ranked by the highest vaccination rate as of Feb. 24, 2022. Due to inconsistencies in reporting, some counties do not have vaccination data available. Keep reading to see whether your county ranks among the highest COVID-19 vaccination rates in your state.
Population that is fully vaccinated: 47.6% (37,457 fully vaccinated) 32.0% lower vaccination rate than California Cumulative deaths per 100k: 139 (109 total deaths) 33.2% less deaths per 100k residents than California Cumulative cases per 100k: 21,007 (16,526 total cases) 6.1% less cases per 100k residents than California
Population that is fully vaccinated: 48.2% (5,921 fully vaccinated) 31.1% lower vaccination rate than California Cumulative deaths per 100k: 163 (20 total deaths) 21.6% less deaths per 100k residents than California Cumulative cases per 100k: 11,380 (1,398 total cases) 49.2% less cases per 100k residents than California
Population that is fully vaccinated: 50.0% (138,829 fully vaccinated) 28.6% lower vaccination rate than California Cumulative deaths per 100k: 275 (763 total deaths) 32.2% more deaths per 100k residents than California Cumulative cases per 100k: 24,217 (67,246 total cases) 8.2% more cases per 100k residents than California
Population that is fully vaccinated: 51.4% (28,018 fully vaccinated) 26.6% lower vaccination rate than California Cumulative deaths per 100k: 314 (171 total deaths) 51.0% more deaths per 100k residents than California Cumulative cases per 100k: 22,918 (12,485 total cases) 2.4% more cases per 100k residents than California
Population that is fully vaccinated: 51.7% (20,536 fully vaccinated) 26.1% lower vaccination rate than California Cumulative deaths per 100k: 194 (77 total deaths) 6.7% less deaths per 100k residents than California Cumulative cases per 100k: 22,152 (8,806 total cases) 1.0% less cases per 100k residents than California
Population that is fully vaccinated: 52.0% (1,562 fully vaccinated) 25.7% lower vaccination rate than California Cumulative deaths per 100k: 0 (0 total deaths) 100.0% less deaths per 100k residents than California Cumulative cases per 100k: 10,349 (311 total cases) 53.8% less cases per 100k residents than California
Population that is fully vaccinated: 52.1% (114,210 fully vaccinated) 25.6% lower vaccination rate than California Cumulative deaths per 100k: 165 (361 total deaths) 20.7% less deaths per 100k residents than California Cumulative cases per 100k: 17,479 (38,312 total cases) 21.9% less cases per 100k residents than California
Population that is fully vaccinated: 52.1% (469,101 fully vaccinated) 25.6% lower vaccination rate than California Cumulative deaths per 100k: 230 (2,072 total deaths) 10.6% more deaths per 100k residents than California Cumulative cases per 100k: 24,978 (224,854 total cases) 11.6% more cases per 100k residents than California
Population that is fully vaccinated: 52.5% (24,094 fully vaccinated) 25.0% lower vaccination rate than California Cumulative deaths per 100k: 231 (106 total deaths) 11.1% more deaths per 100k residents than California Cumulative cases per 100k: 16,327 (7,495 total cases) 27.0% less cases per 100k residents than California
Population that is fully vaccinated: 52.7% (245,687 fully vaccinated) 24.7% lower vaccination rate than California Cumulative deaths per 100k: 274 (1,278 total deaths) 31.7% more deaths per 100k residents than California Cumulative cases per 100k: 27,618 (128,752 total cases) 23.4% more cases per 100k residents than California
Population that is fully vaccinated: 52.8% (83,132 fully vaccinated) 24.6% lower vaccination rate than California Cumulative deaths per 100k: 210 (330 total deaths) 1.0% more deaths per 100k residents than California Cumulative cases per 100k: 26,634 (41,903 total cases) 19.0% more cases per 100k residents than California
Population that is fully vaccinated: 53.7% (34,585 fully vaccinated) 23.3% lower vaccination rate than California Cumulative deaths per 100k: 191 (123 total deaths) 8.2% less deaths per 100k residents than California Cumulative cases per 100k: 16,859 (10,855 total cases) 24.7% less cases per 100k residents than California
Population that is fully vaccinated: 53.9% (15,300 fully vaccinated) 23.0% lower vaccination rate than California Cumulative deaths per 100k: 137 (39 total deaths) 34.1% less deaths per 100k residents than California Cumulative cases per 100k: 22,467 (6,379 total cases) 0.4% more cases per 100k residents than California
Population that is fully vaccinated: 54.2% (10,201 fully vaccinated) 22.6% lower vaccination rate than California Cumulative deaths per 100k: 69 (13 total deaths) 66.8% less deaths per 100k residents than California Cumulative cases per 100k: 15,893 (2,989 total cases) 29.0% less cases per 100k residents than California
Population that is fully vaccinated: 55.5% (1,209,682 fully vaccinated) 20.7% lower vaccination rate than California Cumulative deaths per 100k: 292 (6,372 total deaths) 40.4% more deaths per 100k residents than California Cumulative cases per 100k: 26,407 (575,690 total cases) 18.0% more cases per 100k residents than California
Population that is fully vaccinated: 55.6% (305,969 fully vaccinated) 20.6% lower vaccination rate than California Cumulative deaths per 100k: 260 (1,429 total deaths) 25.0% more deaths per 100k residents than California Cumulative cases per 100k: 23,846 (131,310 total cases) 6.5% more cases per 100k residents than California
Population that is fully vaccinated: 57.5% (1,419,737 fully vaccinated) 17.9% lower vaccination rate than California Cumulative deaths per 100k: 245 (6,049 total deaths) 17.8% more deaths per 100k residents than California Cumulative cases per 100k: 24,574 (607,114 total cases) 9.8% more cases per 100k residents than California
Population that is fully vaccinated: 58.8% (12,674 fully vaccinated) 16.0% lower vaccination rate than California Cumulative deaths per 100k: 97 (21 total deaths) 53.4% less deaths per 100k residents than California Cumulative cases per 100k: 20,509 (4,419 total cases) 8.4% less cases per 100k residents than California
Population that is fully vaccinated: 58.8% (57,033 fully vaccinated) 16.0% lower vaccination rate than California Cumulative deaths per 100k: 216 (209 total deaths) 3.8% more deaths per 100k residents than California Cumulative cases per 100k: 22,425 (21,746 total cases) 0.2% more cases per 100k residents than California
Population that is fully vaccinated: 59.5% (453,453 fully vaccinated) 15.0% lower vaccination rate than California Cumulative deaths per 100k: 265 (2,021 total deaths) 27.4% more deaths per 100k residents than California Cumulative cases per 100k: 22,561 (171,946 total cases) 0.8% more cases per 100k residents than California
Population that is fully vaccinated: 59.5% (594,636 fully vaccinated) 15.0% lower vaccination rate than California Cumulative deaths per 100k: 255 (2,543 total deaths) 22.6% more deaths per 100k residents than California Cumulative cases per 100k: 24,349 (243,273 total cases) 8.8% more cases per 100k residents than California
Population that is fully vaccinated: 60.1% (115,817 fully vaccinated) 14.1% lower vaccination rate than California Cumulative deaths per 100k: 98 (189 total deaths) 52.9% less deaths per 100k residents than California Cumulative cases per 100k: 15,080 (29,080 total cases) 32.6% less cases per 100k residents than California
Population that is fully vaccinated: 61.0% (10,995 fully vaccinated) 12.9% lower vaccination rate than California Cumulative deaths per 100k: 288 (52 total deaths) 38.5% more deaths per 100k residents than California Cumulative cases per 100k: 24,713 (4,458 total cases) 10.4% more cases per 100k residents than California
Population that is fully vaccinated: 62.1% (61,965 fully vaccinated) 11.3% lower vaccination rate than California Cumulative deaths per 100k: 121 (121 total deaths) 41.8% less deaths per 100k residents than California Cumulative cases per 100k: 16,903 (16,862 total cases) 24.5% less cases per 100k residents than California
Population that is fully vaccinated: 62.3% (9,003 fully vaccinated) 11.0% lower vaccination rate than California Cumulative deaths per 100k: 35 (5 total deaths) 83.2% less deaths per 100k residents than California Cumulative cases per 100k: 21,255 (3,070 total cases) 5.0% less cases per 100k residents than California
Population that is fully vaccinated: 63.2% (178,956 fully vaccinated) 9.7% lower vaccination rate than California Cumulative deaths per 100k: 148 (419 total deaths) 28.8% less deaths per 100k residents than California Cumulative cases per 100k: 19,204 (54,369 total cases) 14.2% less cases per 100k residents than California
Population that is fully vaccinated: 63.6% (718 fully vaccinated) 9.1% lower vaccination rate than California Cumulative deaths per 100k: 0 (0 total deaths) 100.0% less deaths per 100k residents than California Cumulative cases per 100k: 11,160 (126 total cases) 50.1% less cases per 100k residents than California
Population that is fully vaccinated: 65.1% (88,209 fully vaccinated) 7.0% lower vaccination rate than California Cumulative deaths per 100k: 97 (132 total deaths) 53.4% less deaths per 100k residents than California Cumulative cases per 100k: 14,065 (19,066 total cases) 37.2% less cases per 100k residents than California
Population that is fully vaccinated: 65.2% (292,077 fully vaccinated) 6.9% lower vaccination rate than California Cumulative deaths per 100k: 95 (427 total deaths) 54.3% less deaths per 100k residents than California Cumulative cases per 100k: 18,736 (83,869 total cases) 16.3% less cases per 100k residents than California
Population that is fully vaccinated: 65.5% (260,819 fully vaccinated) 6.4% lower vaccination rate than California Cumulative deaths per 100k: 139 (554 total deaths) 33.2% less deaths per 100k residents than California Cumulative cases per 100k: 17,158 (68,344 total cases) 23.3% less cases per 100k residents than California
Population that is fully vaccinated: 65.8% (1,021,348 fully vaccinated) 6.0% lower vaccination rate than California Cumulative deaths per 100k: 175 (2,721 total deaths) 15.9% less deaths per 100k residents than California Cumulative cases per 100k: 19,035 (295,432 total cases) 15.0% less cases per 100k residents than California
Population that is fully vaccinated: 67.4% (58,505 fully vaccinated) 3.7% lower vaccination rate than California Cumulative deaths per 100k: 124 (108 total deaths) 40.4% less deaths per 100k residents than California Cumulative cases per 100k: 17,606 (15,273 total cases) 21.3% less cases per 100k residents than California
Population that is fully vaccinated: 67.9% (303,002 fully vaccinated) 3.0% lower vaccination rate than California Cumulative deaths per 100k: 143 (640 total deaths) 31.3% less deaths per 100k residents than California Cumulative cases per 100k: 19,769 (88,267 total cases) 11.7% less cases per 100k residents than California
Population that is fully vaccinated: 69.1% (152,441 fully vaccinated) 1.3% lower vaccination rate than California Cumulative deaths per 100k: 131 (289 total deaths) 37.0% less deaths per 100k residents than California Cumulative cases per 100k: 17,389 (38,342 total cases) 22.3% less cases per 100k residents than California
Population that is fully vaccinated: 70.4% (44,192 fully vaccinated) 0.6% higher vaccination rate than California Cumulative deaths per 100k: 145 (91 total deaths) 30.3% less deaths per 100k residents than California Cumulative cases per 100k: 20,915 (13,136 total cases) 6.6% less cases per 100k residents than California
Population that is fully vaccinated: 70.6% (306,525 fully vaccinated) 0.9% higher vaccination rate than California Cumulative deaths per 100k: 157 (682 total deaths) 24.5% less deaths per 100k residents than California Cumulative cases per 100k: 20,378 (88,451 total cases) 8.9% less cases per 100k residents than California
Population that is fully vaccinated: 70.7% (597,890 fully vaccinated) 1.0% higher vaccination rate than California Cumulative deaths per 100k: 162 (1,372 total deaths) 22.1% less deaths per 100k residents than California Cumulative cases per 100k: 21,184 (179,216 total cases) 5.3% less cases per 100k residents than California
Population that is fully vaccinated: 71.5% (2,269,354 fully vaccinated) 2.1% higher vaccination rate than California Cumulative deaths per 100k: 201 (6,374 total deaths) 3.4% less deaths per 100k residents than California Cumulative cases per 100k: 18,188 (577,597 total cases) 18.7% less cases per 100k residents than California
Population that is fully vaccinated: 71.8% (7,207,914 fully vaccinated) 2.6% higher vaccination rate than California Cumulative deaths per 100k: 296 (29,691 total deaths) 42.3% more deaths per 100k residents than California Cumulative cases per 100k: 27,463 (2,757,043 total cases) 22.7% more cases per 100k residents than California
Population that is fully vaccinated: 74.0% (202,124 fully vaccinated) 5.7% higher vaccination rate than California Cumulative deaths per 100k: 92 (250 total deaths) 55.8% less deaths per 100k residents than California Cumulative cases per 100k: 17,280 (47,212 total cases) 22.8% less cases per 100k residents than California
Population that is fully vaccinated: 77.0% (380,819 fully vaccinated) 10.0% higher vaccination rate than California Cumulative deaths per 100k: 87 (431 total deaths) 58.2% less deaths per 100k residents than California Cumulative cases per 100k: 16,706 (82,584 total cases) 25.4% less cases per 100k residents than California
Population that is fully vaccinated: 77.7% (106,974 fully vaccinated) 11.0% higher vaccination rate than California Cumulative deaths per 100k: 92 (127 total deaths) 55.8% less deaths per 100k residents than California Cumulative cases per 100k: 18,709 (25,771 total cases) 16.4% less cases per 100k residents than California
Population that is fully vaccinated: 80.0% (2,670,929 fully vaccinated) 14.3% higher vaccination rate than California Cumulative deaths per 100k: 147 (4,914 total deaths) 29.3% less deaths per 100k residents than California Cumulative cases per 100k: 23,190 (774,146 total cases) 3.6% more cases per 100k residents than California
Population that is fully vaccinated: 80.2% (1,340,020 fully vaccinated) 14.6% higher vaccination rate than California Cumulative deaths per 100k: 101 (1,683 total deaths) 51.4% less deaths per 100k residents than California Cumulative cases per 100k: 15,562 (260,093 total cases) 30.5% less cases per 100k residents than California
Population that is fully vaccinated: 81.0% (934,099 fully vaccinated) 15.7% higher vaccination rate than California Cumulative deaths per 100k: 102 (1,179 total deaths) 51.0% less deaths per 100k residents than California Cumulative cases per 100k: 16,913 (195,099 total cases) 24.4% less cases per 100k residents than California
Population that is fully vaccinated: 82.7% (729,192 fully vaccinated) 18.1% higher vaccination rate than California Cumulative deaths per 100k: 86 (756 total deaths) 58.7% less deaths per 100k residents than California Cumulative cases per 100k: 14,690 (129,496 total cases) 34.4% less cases per 100k residents than California
Population that is fully vaccinated: 83.2% (637,551 fully vaccinated) 18.9% higher vaccination rate than California Cumulative deaths per 100k: 78 (595 total deaths) 62.5% less deaths per 100k residents than California Cumulative cases per 100k: 16,138 (123,709 total cases) 27.9% less cases per 100k residents than California
Population that is fully vaccinated: 84.4% (1,626,513 fully vaccinated) 20.6% higher vaccination rate than California Cumulative deaths per 100k: 110 (2,130 total deaths) 47.1% less deaths per 100k residents than California Cumulative cases per 100k: 16,320 (314,619 total cases) 27.1% less cases per 100k residents than California
Population that is fully vaccinated: 86.3% (223,426 fully vaccinated) 23.3% higher vaccination rate than California Cumulative deaths per 100k: 99 (255 total deaths) 52.4% less deaths per 100k residents than California Cumulative cases per 100k: 13,828 (35,791 total cases) 38.2% less cases per 100k residents than California
Population that is fully vaccinated: 87.8% (159,066 fully vaccinated) 25.4% higher vaccination rate than California Cumulative deaths per 100k: 475 (860 total deaths) 128.4% more deaths per 100k residents than California Cumulative cases per 100k: 35,418 (64,183 total cases) 58.3% more cases per 100k residents than California
The threat of new coronavirus variants remains a focus for the world's leading public health experts, even as some wealthier and more vaccinated countries push for a return to normal.
It's why Bill Gates angered some experts over the weekend when he said it's too late to meet the World Health Organization's global vaccination goal of 70% and that there is no longer demand for vaccines. He added that with natural immunity from the virus, much of the African continent has a higher level of protection.
"You get well over 80% of people have been exposed either to the vaccine or to various variants," Gates said at the Munich Security Conference.
"What that does is, it means the chance of severe disease ... those risks are now dramatically reduced because of that infection exposure," he added.
But experts at the first global Ports To Arms Summit in Abuja, Nigeria, on Wednesday sharply disagreed with Gates.
Dr. Seth Berkley, CEO of Gavi, the global vaccine alliance, said that even if we are tired of the virus, it is not tired of us.
"We've had a new variant every 4-5 months; it's likely that there will still be new variants. They may or may not be more severe," he said in response to a question from Yahoo Finance.
"What's important to keep in mind is that previous variants have not necessarily protected against new variants," Berkley added.
Dr. Atul Gawande, assistant administrator for global health for USAID, pointed out that the 70% goal is the minimum goal and that number has broader implications for the overall pandemic.
"That's the only way we will be able to stop the generation of more variants," especially to protect the most vulnerable segments of the world's population, he said.
His comments come at a time when the African continent remains largely unvaccinated with just over 10% fully vaccinated.
Kate O'Brien, executive director of the WHO's Internal Vaccine Access Center, told Yahoo Finance that the 70% goal does include flexibility and considers country-by-country needs.
Story continues
"The strategy does talk about adaptation ... as the pandemic evolves. I don't want anybody to misperceive that this...is sort of written in stone in any way," O'Brien said.
But the issue is no longer a vaccine shortage, but rather an oversupply. The problem arose as African nations struggled to manage constantly changing supply promises, which lead to scrambling plans on the ground to ramp up infrastructure to get the shots in arms.
It's why John Nkengasong, Africa CDC director, is asking for a pause on all global donations until the third or fourth quarter this year.
However, that doesn't mean that the urgency to vaccinate has subsided.
"If you look at the death numbers, things are not changing very quickly at all. We still have a pandemic around the world," O'Brien said.
"There is still a race to vaccinate," she added.
Richard Hatchett, CEO of Coalition for Epidemic Preparedness Innovations (CEPI), said that rather than calling for an "end to the virus" in areas of high vaccination, the focus should instead be on the long term outlook.
"We need to be thinking about the vaccines we want to have in three to five years when this virus is still with us still mutating, still changing," he said.
Dr. Matshidiso Moeti, regional director for Africa WHO, added that the ultimate goal is to provide protection against severe illness and minimizing deaths in those who contract the virus, even if vaccinated.
She pointed to a roadmap created by the WHO to prioritize the most vulnerable.
Recent studies have shown that even with natural protection from the virus, a single dose of a vaccine can provide much better protection for individuals.
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NEW YORK AND MAINZ, GERMANY, February 24, 2022 Pfizer Inc. (NYSE: PFE, Pfizer) and BioNTech SE (Nasdaq: BNTX, BioNTech) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies COVID-19 vaccine COMIRNATY as a booster dose (30ug) at least six months after the second dose in adolescents 12 through 17 years of age. The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future. If the EC grants the variation, the decision will be immediately applicable to all 27 EU member states, making booster vaccines available to everyone 12 years and older.
The positive opinion adopted by the CHMP is based on an evaluation of interim safety and efficacy data from a clinical trial of a booster dose of the vaccine in those aged 16 and over, together with published literature and post authorisation data plus real-world evidence from the use of booster doses in young patients in Israel. The Committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults. No new safety concerns were identified from the data available.
The COVID-19 vaccine booster for individuals 12 through 15 years of age was already granted Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) earlier this year as an expansion to the existing EUA for the primary series. The companies are also planning to file the data with other regulatory authorities in the coming weeks. The Pfizer-BioNTech COVID-19 Vaccine is currently the only COVID-19 vaccine authorized for this age group both in a primary series as well as a booster in the U.S. and Europe.
Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the EC. The companies do not expect the introduction of booster doses for adolescents 12 through 17 years of age in the EU, if authorized, to impact the existing supply agreements in place with governments and international health organizations around the world.
COMIRNATY, which is based on BioNTechs proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of Emergency Use Authorizations or equivalents in the United States (jointly with Pfizer) and other countries.
U.S. Indication & Authorized UseHOW IS THE VACCINE GIVEN?
The vaccine will be given as an injection into the muscle.
Primary Series:In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart. In individuals 12 years of age and older, a third primary series dose may be administered at least 4 weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise.
Booster Dose:
WHAT IS THE INDICATION AND AUTHORIZED USE?
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:
COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
EUA StatementEmergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheets at www.cvdvaccine-us.com.
IMPORTANT SAFETY INFORMATIONIndividuals should not get the vaccine if they:
Individuals should tell the vaccination provider about all of their medical conditions, including if they:
The vaccine may not protect everyone.
Side effects reported with the vaccine include:
Data on administration of this vaccine at the same time as other vaccines have not yet been submitted to FDA. Individuals considering receiving this vaccine with other vaccines, should discuss their options with their healthcare provider.
Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://www.vaers.hhs.gov or call 1-800-822-7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
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Fact Sheets and Prescribing Information for individuals 12 years of age and olderFull Prescribing Information (16 years of age and older)EUA Fact Sheet for Vaccination Providers (12 years of age and older), Purple CapEUA Fact Sheet for Vaccination Providers (12 years of age and older), Gray CapRecipients and Caregivers Fact Sheet (12 years of age and older)
Fact Sheets for individuals 5 through 11 years of ageEUA Fact Sheet for Vaccination Providers (5 through 11 years of age), Orange CapRecipients and Caregivers Fact Sheet (5 through 11 years of age)
About Pfizer: Breakthroughs That Change Patients LivesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure NoticeThe information contained in this release is as of February 24, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizers efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including a potential booster dose and a potential variation of the conditional marketing authorization of BNT162b2 in the EU to include the administration of a booster dose in adolescents 12 through 17 years of age, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1/2/3 or Phase 4 data) for BNT162b2 or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 or any future vaccine to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for BNT162b2 in additional populations, for a potential booster dose, for BNT162b2 or any potential future vaccines (including potential future annual boosters or re-vaccinations) and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, including a potential variant based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including the potential variation of the conditional marketing authorization of BNT162b2 in the EU to include the administration of a booster dose in adolescents 12 through 17 years of age and any requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccines benefits outweigh its known risks and determination of the vaccines efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccines formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant based vaccines; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizers business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
About BioNTechBiopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.
BioNTech Forward-looking StatementsThis press release contains forward-looking statements of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTechs efforts to combat COVID-19; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) (including including a potential booster dose and a potential variation of the conditional marketing authorization of BNT162b2 in the European Union to include the administration of a booster dose in adolescents 12 through 17 years of age, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials, real world data studies, and/or in commercial use based on data observations to date; the ability of BNT162b2 or a future vaccine to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for BNT162, or any future vaccine, in additional populations, or receipt of, any marketing approval or emergency use authorization or equivalent, including or amendments or variations to such authorizations; the development of other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant based vaccines; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2022; challenges related to public vaccine confidence or awareness; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; the availability of raw material to manufacture BNT162 or other vaccine formulation; challenges related to our vaccines formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery; and uncertainties regarding the impact of COVID-19 on BioNTechs trials, business and general operations. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.
For a discussion of these and other risks and uncertainties, see BioNTechs Annual Report as Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SECs website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.
CONTACTS
Pfizer:Media Relations+44 1737332335[emailprotected]
Investor Relations+1 (212) 733-4848[emailprotected]
BioNTech:Media RelationsJasmina Alatovic+49 (0)6131 9084 1513[emailprotected]
Investor RelationsSylke Maas, Ph.D.+49 (0)6131 9084 1074[emailprotected]
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